US20200194771A1 - Medical electrodes having enhanced charge capacities, and methods of manufacturing - Google Patents
Medical electrodes having enhanced charge capacities, and methods of manufacturing Download PDFInfo
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- US20200194771A1 US20200194771A1 US16/712,931 US201916712931A US2020194771A1 US 20200194771 A1 US20200194771 A1 US 20200194771A1 US 201916712931 A US201916712931 A US 201916712931A US 2020194771 A1 US2020194771 A1 US 2020194771A1
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- conductive material
- laser
- electrodes
- electrode
- laser process
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- H—ELECTRICITY
- H01—ELECTRIC ELEMENTS
- H01M—PROCESSES OR MEANS, e.g. BATTERIES, FOR THE DIRECT CONVERSION OF CHEMICAL ENERGY INTO ELECTRICAL ENERGY
- H01M4/00—Electrodes
- H01M4/02—Electrodes composed of, or comprising, active material
- H01M4/04—Processes of manufacture in general
- H01M4/0402—Methods of deposition of the material
- H01M4/0404—Methods of deposition of the material by coating on electrode collectors
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/04—Electrodes
- A61N1/0404—Electrodes for external use
- A61N1/0408—Use-related aspects
- A61N1/0456—Specially adapted for transcutaneous electrical nerve stimulation [TENS]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/04—Electrodes
- A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
- A61N1/0551—Spinal or peripheral nerve electrodes
-
- C—CHEMISTRY; METALLURGY
- C25—ELECTROLYTIC OR ELECTROPHORETIC PROCESSES; APPARATUS THEREFOR
- C25D—PROCESSES FOR THE ELECTROLYTIC OR ELECTROPHORETIC PRODUCTION OF COATINGS; ELECTROFORMING; APPARATUS THEREFOR
- C25D3/00—Electroplating: Baths therefor
- C25D3/02—Electroplating: Baths therefor from solutions
- C25D3/48—Electroplating: Baths therefor from solutions of gold
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- H01L51/0037—
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02E—REDUCTION OF GREENHOUSE GAS [GHG] EMISSIONS, RELATED TO ENERGY GENERATION, TRANSMISSION OR DISTRIBUTION
- Y02E60/00—Enabling technologies; Technologies with a potential or indirect contribution to GHG emissions mitigation
- Y02E60/10—Energy storage using batteries
Definitions
- the present application generally relates electrodes for delivering energy or stimulus to tissue or structure of the body. More specifically, the application relates to electrode manufacturing processes.
- delivery of the parasympathetic and sympathetic therapy decreases the patient's heart rate (through the delivery of therapy to the parasympathetic nerves) and elevates or maintains the blood pressure (through the delivery of therapy to the cardiac sympathetic nerves) of the patient in treatment of heart failure.
- the '699 and '560 applications describe one form of catheter device that may be used to perform transvascular neuromodulation.
- these applications shows a support or electrode carrying member 10 of the type shown in FIG. 1 on the distal part of a catheter member 4 .
- the electrode carrying member 10 includes a plurality of struts 12 .
- One or more of the struts carries one or a plurality of electrodes 17 .
- the electrode carrying member 10 is designed to bias such electrodes into contact with the vessel wall.
- the material forming the struts 12 may have a shape set or shape memory that aids in biasing the circumferentially-outward facing surfaces (and thus the electrodes) against the vessel wall.
- the applications describe that the electrodes 17 may be mounted to or formed onto a substrate 15 that is itself mounted onto a strut or a plurality of strut. It is also disclosed that the struts and electrodes may use flex circuit or printed circuit elements.
- the rivet is then subjected to a heating process that causes the end of the shank to expand radially and compress longitudinally, forming a secondary head on the opposite end of the shank from the first head.
- the flexible circuit and strut are thus fixed to one another, captured between the primary head and secondary head of the rivet.
- Electrodes described in the present application may be used to create an electrode surface, which may on a flex circuit, capable of achieving the current densities needed to carry out the therapy performed in the referenced applications, and for the durations at which therapy could be applied in the acute setting (e.g. up to 96 hours).
- FIG. 1 shows an electrode carrying member of the type shown in the '699 and '560 applications, with electrodes carried thereon.
- FIG. 2A shows components of an electrode carrying member prior to assembly, and illustrates a method of assembling the flexible circuit to a strut on the array.
- FIG. 2B shows the electrode carrying member following assembly with the flexible circuit.
- FIG. 3A is a flow diagram showing a sequence of steps in a first manufacturing method for enhancing the charge capacity of electrodes.
- FIG. 3B is a flow diagram showing a sequence of steps in a second manufacturing method for enhancing the charge capacity of electrodes.
- This application describes processes that may be used to create an electrode surface capable of achieving the current densities needed to carry out the therapy performed in the referenced applications, and for the durations at which therapy could be applied in the acute setting (e.g. up to 96 hours).
- These processes make use of a laser skiving process or other suitable process to enhance the topography of the electrodes, thus making the electrodes cable of achieving higher charge capacities, and they additionally apply a high specific surface area materials (e.g. IrOx or PEDOT) to the electrode surface to further increase the effective surface area and thus the storage capacity of the electrode surface.
- a high specific surface area materials e.g. IrOx or PEDOT
- a flexible circuit is created using flex circuit manufacturing techniques known to those skilled in the art.
- the flex circuit is plated with thick, electrolytic hard gold plating.
- a cover layer is applied over the gold electrode surface using an adhesive or adhesiveless process.
- Step 304 a laser is used to skive the flex circuit. This initial skiving step removes portions of the cover layer to expose electrodes on the flex circuit.
- the electrodes have an obround geometry, but in other examples electrodes of any shape may be formed.
- a second laser skiving step is performed in step 308 .
- a skiving laser is passed over the flex circuit to create increased roughness in the gold electrode material and to remove impurities from the coating surface.
- the gold electrode surface is coated with a high specific area coating, preferably using electrical deposition. A cyclic voltammetry test may be performed on the electrodes to verify their capability.
- FIG. 3B A second example of a manufacturing process 400 is shown in FIG. 3B .
- a flexible circuit is created using flex circuit manufacturing techniques known to those skilled in the art.
- the flex circuit is plated with thick, electrolytic hard gold plating.
- Step 402 A laser skiving step is performed in step 404 .
- a skiving laser is passed over the flex circuit to create increased roughness in the gold electrode material and to remove impurities.
- the gold electrode surface is coated with a high specific area coating, preferably using electrical deposition. A cyclic voltammetry test may be performed on the electrodes to verify their capability.
- the processes described above result in creation of a flexible circuit having one or more electrodes, each of which possesses an electrode surface particularly suitable for transvascular stimulation of nerve targets in therapies such as those described in the referenced applications, which require high charge densities over extended time periods (e.g. up to 96 hours).
- the flexible circuits may be mounted to electrode carrying members such as the strut arrangements described above with respect to FIGS. 1-2B , or alternative electrode carrying members for intravascular or extravascular use.
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- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Electrochemistry (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Biomedical Technology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Radiology & Medical Imaging (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Neurosurgery (AREA)
- Cardiology (AREA)
- Neurology (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Heart & Thoracic Surgery (AREA)
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- Organic Chemistry (AREA)
- Electrotherapy Devices (AREA)
Abstract
Description
- This application claims the benefit of U.S. Provisional Application No. 62/772,352, filed Dec. 12, 2019.
- The present application generally relates electrodes for delivering energy or stimulus to tissue or structure of the body. More specifically, the application relates to electrode manufacturing processes.
- Co-pending U.S. application Ser. No. 13/547,031 entitled System and Method for Acute Neuromodulation, filed Jul. 11, 2012 (Attorney Docket: IAC-1260; the “'031 application”), filed by an entity engaged in research with the owner of the present application, describes a system which may be used for hemodynamic control in the acute hospital care setting, by transvascularly directing therapeutic stimulus to parasympathetic nerves and/or sympathetic cardiac nerves using electrodes positioned in the superior vena cava (SVC). In disclosed embodiments, delivery of the parasympathetic and sympathetic therapy decreases the patient's heart rate (through the delivery of therapy to the parasympathetic nerves) and elevates or maintains the blood pressure (through the delivery of therapy to the cardiac sympathetic nerves) of the patient in treatment of heart failure.
- Co-pending U.S. application Ser. No. 14/642,699 (the '699), filed Mar. 9, 2015 and U.S. Ser. No. 14/801,560 (the '560), filed Jul. 16, 2015, each incorporated by reference, describe transvascularly directing therapeutic stimulus to parasympathetic and/or sympathetic cardiac nerves using electrodes positioned in the SVC, right brachiocephalic vein, and/or left brachiocephalic vein and/or other sites. As with the system disclosed in the '031, the methods disclosed in these applications can decrease the patient's heart rate (through the delivery of therapy to the parasympathetic nerves) and elevate or maintain the blood pressure (through the delivery of therapy to the cardiac sympathetic nerves) of the patient in treatment of heart failure.
- The '699 and '560 applications describe one form of catheter device that may be used to perform transvascular neuromodulation. In particular, these applications shows a support or
electrode carrying member 10 of the type shown inFIG. 1 on the distal part of acatheter member 4. Theelectrode carrying member 10 includes a plurality of struts 12. One or more of the struts carries one or a plurality ofelectrodes 17. Theelectrode carrying member 10 is designed to bias such electrodes into contact with the vessel wall. The material forming the struts 12 may have a shape set or shape memory that aids in biasing the circumferentially-outward facing surfaces (and thus the electrodes) against the vessel wall. The applications describe that theelectrodes 17 may be mounted to or formed onto asubstrate 15 that is itself mounted onto a strut or a plurality of strut. It is also disclosed that the struts and electrodes may use flex circuit or printed circuit elements. - Co-pending and commonly owned U.S. application Ser. No. ______ (Attorney Ref: NTK2-2010), filed Dec. 12, 2019 and incorporated herein by reference, describes electrode support assemblies in which flexible circuits (having electrodes and/or other components on them) may be mounted to an electrode support. Referring to
FIGS. 2A and 2B , the method makes use of a heat staking process to fix aflexible circuit 100 to astrut 102, such as a shape memory strut formed of nitinol or alternative material. The flexible circuit includes theelectrodes 103. In general, to carry out the method, the shank of the rivet is passed through a hole 110 in the flexible circuit and an aligned hole 112 in the strut as indicated inFIG. 2A . The rivet is then subjected to a heating process that causes the end of the shank to expand radially and compress longitudinally, forming a secondary head on the opposite end of the shank from the first head. The flexible circuit and strut are thus fixed to one another, captured between the primary head and secondary head of the rivet. - Concepts described in the present application may be used to create an electrode surface, which may on a flex circuit, capable of achieving the current densities needed to carry out the therapy performed in the referenced applications, and for the durations at which therapy could be applied in the acute setting (e.g. up to 96 hours).
-
FIG. 1 shows an electrode carrying member of the type shown in the '699 and '560 applications, with electrodes carried thereon. -
FIG. 2A shows components of an electrode carrying member prior to assembly, and illustrates a method of assembling the flexible circuit to a strut on the array.FIG. 2B shows the electrode carrying member following assembly with the flexible circuit. -
FIG. 3A is a flow diagram showing a sequence of steps in a first manufacturing method for enhancing the charge capacity of electrodes. -
FIG. 3B is a flow diagram showing a sequence of steps in a second manufacturing method for enhancing the charge capacity of electrodes. - This application describes processes that may be used to create an electrode surface capable of achieving the current densities needed to carry out the therapy performed in the referenced applications, and for the durations at which therapy could be applied in the acute setting (e.g. up to 96 hours). These processes make use of a laser skiving process or other suitable process to enhance the topography of the electrodes, thus making the electrodes cable of achieving higher charge capacities, and they additionally apply a high specific surface area materials (e.g. IrOx or PEDOT) to the electrode surface to further increase the effective surface area and thus the storage capacity of the electrode surface.
- In accordance with a first example of an
electrode manufacturing method 300 illustrated inFIG. 3A , a flexible circuit is created using flex circuit manufacturing techniques known to those skilled in the art. The flex circuit is plated with thick, electrolytic hard gold plating.Step 302. A cover layer is applied over the gold electrode surface using an adhesive or adhesiveless process.Step 304. Instep 306, a laser is used to skive the flex circuit. This initial skiving step removes portions of the cover layer to expose electrodes on the flex circuit. In preferred examples, the electrodes have an obround geometry, but in other examples electrodes of any shape may be formed. A second laser skiving step is performed instep 308. In this second skiving step, a skiving laser is passed over the flex circuit to create increased roughness in the gold electrode material and to remove impurities from the coating surface. Finally, instep 310, the gold electrode surface is coated with a high specific area coating, preferably using electrical deposition. A cyclic voltammetry test may be performed on the electrodes to verify their capability. - A second example of a
manufacturing process 400 is shown inFIG. 3B . In this embodiment, a flexible circuit is created using flex circuit manufacturing techniques known to those skilled in the art. The flex circuit is plated with thick, electrolytic hard gold plating.Step 402. A laser skiving step is performed instep 404. In this skiving step, a skiving laser is passed over the flex circuit to create increased roughness in the gold electrode material and to remove impurities. Finally, instep 406, the gold electrode surface is coated with a high specific area coating, preferably using electrical deposition. A cyclic voltammetry test may be performed on the electrodes to verify their capability. - The processes described above result in creation of a flexible circuit having one or more electrodes, each of which possesses an electrode surface particularly suitable for transvascular stimulation of nerve targets in therapies such as those described in the referenced applications, which require high charge densities over extended time periods (e.g. up to 96 hours). The flexible circuits may be mounted to electrode carrying members such as the strut arrangements described above with respect to
FIGS. 1-2B , or alternative electrode carrying members for intravascular or extravascular use. - All applications and patents referred to herein, including for purposes of priority, and incorporated herein by reference.
Claims (13)
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
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US16/712,931 US20200194771A1 (en) | 2018-12-12 | 2019-12-12 | Medical electrodes having enhanced charge capacities, and methods of manufacturing |
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US201862778352P | 2018-12-12 | 2018-12-12 | |
US16/712,931 US20200194771A1 (en) | 2018-12-12 | 2019-12-12 | Medical electrodes having enhanced charge capacities, and methods of manufacturing |
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US20200194771A1 true US20200194771A1 (en) | 2020-06-18 |
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US16/712,931 Abandoned US20200194771A1 (en) | 2018-12-12 | 2019-12-12 | Medical electrodes having enhanced charge capacities, and methods of manufacturing |
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Cited By (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US10952665B2 (en) | 2016-03-09 | 2021-03-23 | CARDIONOMIC, Inc. | Methods of positioning neurostimulation devices |
US11077298B2 (en) | 2018-08-13 | 2021-08-03 | CARDIONOMIC, Inc. | Partially woven expandable members |
US11559687B2 (en) | 2017-09-13 | 2023-01-24 | CARDIONOMIC, Inc. | Methods for detecting catheter movement |
US11607176B2 (en) | 2019-05-06 | 2023-03-21 | CARDIONOMIC, Inc. | Systems and methods for denoising physiological signals during electrical neuromodulation |
US11986650B2 (en) | 2006-12-06 | 2024-05-21 | The Cleveland Clinic Foundation | Methods and systems for treating acute heart failure by neuromodulation |
Citations (5)
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US20130090542A1 (en) * | 2010-06-18 | 2013-04-11 | The Regents Of The University Of Michigan | Implantable micro-component electrodes |
US20130282092A1 (en) * | 2003-05-01 | 2013-10-24 | Second Sight Medical Products, Inc. | Adherent Metal Oxide Coating Forming a High Surface Area Electrode |
US20140357973A1 (en) * | 2013-05-30 | 2014-12-04 | Pulse Technologies, Inc. | Biocompatible implantable electrode |
US20160174860A1 (en) * | 2013-08-15 | 2016-06-23 | Advanced Bionics Ag | Surface modified electrodes |
US20180008821A1 (en) * | 2016-07-05 | 2018-01-11 | Pacesetter, Inc. | Implantable thin film devices |
-
2019
- 2019-12-12 US US16/712,931 patent/US20200194771A1/en not_active Abandoned
Patent Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20130282092A1 (en) * | 2003-05-01 | 2013-10-24 | Second Sight Medical Products, Inc. | Adherent Metal Oxide Coating Forming a High Surface Area Electrode |
US20130090542A1 (en) * | 2010-06-18 | 2013-04-11 | The Regents Of The University Of Michigan | Implantable micro-component electrodes |
US20140357973A1 (en) * | 2013-05-30 | 2014-12-04 | Pulse Technologies, Inc. | Biocompatible implantable electrode |
US20160174860A1 (en) * | 2013-08-15 | 2016-06-23 | Advanced Bionics Ag | Surface modified electrodes |
US20180008821A1 (en) * | 2016-07-05 | 2018-01-11 | Pacesetter, Inc. | Implantable thin film devices |
Cited By (8)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US11986650B2 (en) | 2006-12-06 | 2024-05-21 | The Cleveland Clinic Foundation | Methods and systems for treating acute heart failure by neuromodulation |
US10952665B2 (en) | 2016-03-09 | 2021-03-23 | CARDIONOMIC, Inc. | Methods of positioning neurostimulation devices |
US11229398B2 (en) | 2016-03-09 | 2022-01-25 | CARDIONOMIC, Inc. | Electrode assemblies for neurostimulation treatment |
US11806159B2 (en) | 2016-03-09 | 2023-11-07 | CARDIONOMIC, Inc. | Differential on and off durations for neurostimulation devices and methods |
US11559687B2 (en) | 2017-09-13 | 2023-01-24 | CARDIONOMIC, Inc. | Methods for detecting catheter movement |
US11077298B2 (en) | 2018-08-13 | 2021-08-03 | CARDIONOMIC, Inc. | Partially woven expandable members |
US11648395B2 (en) | 2018-08-13 | 2023-05-16 | CARDIONOMIC, Inc. | Electrode assemblies for neuromodulation |
US11607176B2 (en) | 2019-05-06 | 2023-03-21 | CARDIONOMIC, Inc. | Systems and methods for denoising physiological signals during electrical neuromodulation |
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